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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ChiCTR
Last refreshed on: 18 April 2017
Main ID:  ChiCTR-IPR-15006959
Date of registration: 2015-07-22
Prospective Registration: No
Primary sponsor: Faculty of Medicine Chiang Mai University
Public title: EFFECT OF VITAMIN C ON PHARMACOKINETICS OF GANODERIC ACIDS A AND F AFTER ORAL ADMINISTRATION OF LING ZHI PREPARATION IN HEALTHY THAI MALE VOLUNTEERS
Scientific title: EFFECT OF VITAMIN C ON PHARMACOKINETICS OF GANODERIC ACIDS A AND F AFTER ORAL ADMINISTRATION OF LING ZHI PREPARATION IN HEALTHY THAI MALE VOLUNTEERS
Date of first enrolment: 2014-09-01
Target sample size: healthy Thai male volunteers:12;
Recruitment status: Pending
URL:  http://www.chictr.org.cn/showproj.aspx?proj=11483
Study type:  Interventional study
Study design:  Randomized cross-over control  
Phase:  Pilot study
Countries of recruitment
Thailand
Contacts
Name: Assoc. Prof. Dr. Supanimit Teekachunhatean   
Address:  Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Intawaroros Rd., Tambon Sriphum, Chiang Mai, Thailand 50200
Telephone: +08 8 6491955
Email: doctormit@hotmail.com
Affiliation: 
Name: Patcharanee Tawasri   
Address:  Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Intawaroros Rd., Tambon Sriphum, Chiang Mai, Thailand 50200
Telephone: +08 4 2224151
Email: ii_sikrit@hotmail.com
Affiliation:  Chiang Mai University
Key inclusion & exclusion criteria
Inclusion criteria: Twelve healthy Thai male subjects aged between 18-40 y and body mass index (BMI) within 18.5-24.9 kg/m2 will be enrolled in this study. They will be considered healthy on the basis of their medical history, physical examination and vital signs. The results of routine laboratory tests including complete blood count (CBC), liver function test (LFT), blood urea nitrogen (BUN) and creatinine (Cr) and must be within normal limit to exclude subjects with hematological diseases, abnormal liver and renal functions
Exclusion criteria: Hypersensitivity to Ling Zhi or vitamin c, chronic renal, liver, neurological, pulmonary or cardiovascular diseases including malignancy, history of kidney stones, glucose-6-phosphate dehydrogenase deficiency, bleeding disorders or family history of iron overload/hemochromatosis, recent cigarette smoking within the previous 3 months, alcohol or substance abuse, use of any Ling Zhi preparation or vitamin C or other medications (except acetaminophen) within the previous 1 month.

Age minimum: 18
Age maximum: 40
Gender: Male
Health Condition(s) or Problem(s) studied
HEALTHY THAI MALE VOLUNTEERS
Intervention(s)
healthy Thai male volunteers:Ling zhi;
Primary Outcome(s)
blood level ganoderic acid A and F;
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Faculty of Medicine, Chiang Mai University
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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